BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AffiX Next Gen Spinous Process Plate System

    Reg #: 2031966 · FEI: 3002980729 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NUVASIVE, INC.
    Registration Number
    2031966
    FEI Number
    3002980729
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7475 Lusk Blvd
    City
    SAN DIEGO
    State
    CA
    ZIP
    92121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K133052

    Owner / Operator

    Firm Name
    NUVASIVE, INC.
    Operator Number
    9036345
    Address
    2560 General Armistead Ave, VALLEY FORGE BUSINESS CENTER
    City
    Audubon
    State
    PA
    Postal Code
    19403
    Country
    US
    Correspondent
    Daniel S Paul

    Products

    Device Name Product Code
    Spinous Process Plate PEK

    Proprietary Names

    AffiX Next Gen Spinous Process Plate System

    Establishment Types

    Manufacture Medical Device